Boston Scientific (BSX) 31 Jan 242023 Q4 Earnings call transcript

Good morning, and welcome to the Boston Scientific Fourth Quarter 2023 Earnings Call. [Operator Instructions] Please note this event is being recorded.

I would now like to turn the conference over to Lauren Tengler, Vice President, Investor Relations. Please go ahead.

Thank you, Drew. for today. thanks and everyone, joining us Welcome, With and Brennan, Chief today's call Executive Mahoney, Chairman are Mike Executive Officer. President Chief me and on Vice Financial Officer; and Dan

morning issued announcing XXXX We which of the used reconciliations non-GAAP included release release. press earlier results, our and full a QX year measures in the this

the We reconciliations to measures under non-GAAP today's call Financials of the our a Relations heading used of of release that copy posted Filings. the have as as section Investor well and in website

The this Mike guidance, performance XXXX for of and comments morning's duration outlook approximately call including year X and on and will then hour. as full provide the business, be well we'll as Dan take will the questions. QX your

Mike Chief Dan by and joined Stein. Ken session, Medical Dr. be our will today's During Officer, Q&A

Inc., which Ltd., respectively. excludes investment the Apollo April, February, customary in the is closing Guidance subject XXXX. half to endoscopy divestitures remind revenue divestitures announced begin, to growth revenue fluctuations, the closed February Scientific which call, we like excluded Before further April of include which and expected period the Relievant acquisitions less I'd growth Baylis closed first of conditions. pathology Medical, growth previously majority to for the in that XXXX, net excludes Medical, which and on XX, Acotec closed this sales. foreign on Divestitures and are Endosurgery stake close Holding comparable operational everyone and Relevant XXXX, than a impact Axonics, acquire for currency organic XXXX, there in and November in full of organic business, are agreement excludes which to acquisitions

highlights may refer our financial and found deck, website. For more on to our information, which please Investor Relations be operating

unless are and believe, like identified of words. the product growth savings other this opportunities, which approvals rates, specified, They call, include, This our use, sales expect, about securities anticipated cost forward-looking contains things, as may, acquisitions, within estimate among federal anticipate, references earnings new be by otherwise tax our and organic. words meanings call launches, statements R&D other and revenue, laws, margins all and to On may our and financial growth other spend sales, and statements cash expenses. well flow our as expected clinical and trials, market including performance, similar and share, and

Risk the out our to if be by or subsequent or results update differences Factors include as risks underlying projections implied expressed such with cause Factors actual certain may section in forward-looking materialize, turn our XX-K from of SEC. assumptions or that or them. expectations intention most incorrect the If could date, vary obligation statements to uncertainties our and materially statements. any of we and only the recent and described These today's disclaim XX-Qs speak filed

to it At this Mike. over turn point, I'll

evidence our generation, Lauren, for This thank and you, our everyone, Thanks, we and performance spirit that commercial represented joining exceeding set excellent, goals and by company global today. performance our clinical the us and [indiscernible] of fueled winning for global strongest financial history, the teams. were XXXX in years is the year. of execution results one

versus guidance operational fourth sales quarter XX%. our grew organic full In fourth high of sales 'XX, versus XXXX. guidance exceeding year. XX%, sales company grew sales to while grew XX% of XX% the end year 'XX 'XX, XX% exceeding Full And and quarter approximately organic total our the of of operational growth for range XX% X%

focus on in digits also leadership is This grew double to and double the excellence. our sales our our business testament performance units bolstered XXXX. fourth Importantly, in full for of category and quarter quarter all double innovation X digit and by the our fourth full double year X digits a digits the grew of strategy XXXX commercial year and regions

Fourth operating $X.XX. $X.XX. $X.X XX.X% exceeding was high full the generated to XX.X%, exceeds XXXX, We EPS is was $X.XX full range of year end cash adjusted expectations. 'XX $X.XX our of line of free end which of because $X.XX adjusted grew guidance the levels. margin in with adjusted cash QX pre-pandemic to EPS billion high guidance range versus exceeding $X.X of XX% year flow flow adjusted quarter and Full exciting our also it year ] of our and XXXX, versus $X.XX XX% of grew [ billion,

Now XXXX our outlook. for

We XXXX. X% in to to quarter our guidance first to XXXX the growth for expect healthy and continue to full procedure for X% X% volumes organic of X%

$X.XX Our QX estimate adjusted EPS is 'XX to $X.XX.

year We $X.XX, the to to close $X.XX is excludes the which first of XX%. expect half acquisition Axonics, of This growth EPS adjusted X% guidance to be 'XX. representing to full expected our of in

income goal Despite our pressures in expenses to FX selling adjusted margins operating we and XXXX capacity and our headwinds margin 'XX basis to launches, as in margins manufacturing as 'XX. operating points of on to by remain committed 'XX to from in well investments exciting XXX improving improving fuel in

those XXXX more Now and Dan both will on financials details for XXXX. provide

along operational business strong XX%, additional a basis on Middle on outlook. in our on our ongoing operational now product XXXX year XX% XX% Regionally, grew an and and particular grew basis. comments I'll provide Full EP, an fourth 'XX highlights year versus on with 'XX. with market price Europe, the full and launches 'XX Uro basis, WATCHMAN, execution. grew QX across portfolio, East supported units. is Endo the growth quarter versus XX% results and new discipline commercial by on U.S. It's and Africa above strength

excited particularly further across emerging the within and our in region, markets with with opportunity We're the EMEA momentum growth portfolio, ahead [indiscernible] region. in ongoing the our about year

is a diverse the FLX, on XXXX, major versus XX% portfolio, full year, and execution. grew year growing had This operationally with versus digits products, Pacific Japan basis, Asia a double momentum in for strong notably grew digits. AGENT ongoing WATCHMAN consistent growing 'XX full double ] by and POLAR focus from year [ strong China the new XX% QX markets commercial innovation approximately versus resume DCB fueled growth with and all 'XX FIT most XXXX. strong

sustained ahead, we of our digits mid-teens full billion 'XX talent new chain $X in accretive Looking a capabilities. growing investments 'XX LRP XX% supply full grew and sales over double operationally and over business supported in The grower China product 'XX QX team and X both to launches, to units in basis. our on versus year by agility be in to XXXX, Latin an with America year achieve X expect

[ growth urinary Urology double-digit year direct-to-patient organically. agreement Full was that on and excellent Urology Prosthetic these that includes portfolios we recently I'll within to the globally. to forward prosthetic opportunities our commentary our Urology We led now awareness provide Stone year grew and technologies access BUs. our our quarter. urology Management We're therapy differentiated look ] expanding organic QX a And together a excited growth basis and erectile on by driving XX% patients. growth in devices full company medical relaunched for additional announced franchise. physicians an bowel supporting campaign, some versus for technology Axonics, had dysfunction. bringing XX% acquire about dysfunction XXXX, our 'XX commentary for to and in innovative offers and and

organically. full also growing the operationally fourth were year and operationally growing XX% versus excellent XX% XX% and quarter, and XX% basis quarter organically in sales the Endoscopy 'XX

single-use both year and quarter, double digits, a On AXIOS Within basis, were grew by strong the the excellence. double supported all results scopes, growing new on digits. commercial by and deep focus innovation and led portfolio, regions full broad product

versus versus fourth organically X% and operationally X% X% 'XX. basis, year full quarter X% grew organically sales and Neuromodulation on a 'XX operationally

brain is franchise digits designed [ programming, of Our portfolio efficiency in to deep and both double driven a the our ] innovative and stimulation basis, the improve precise the which the brain full quarter and procedure. grew on year image-guided by precision Genus

which In was our fourth in with organic franchise expectations. on our year-over-year, basis, pain line was quarter, an flat

the fourth back the our portfolio supports excited treatment quarter, our improve FAST of performance expanded NANS. to offer our we're XXXX the real-world including chronic on presented our in and about and the comprehensive to with Intracept launch U.S. expect for acquisition the strong a Relievant now [ novel ability ] data low of with Medsystems completion that recently the algorithm, Alpha of Furthermore, recent pain. indication treatment DPN WaveWriter at in pain We system

were basis growing growing year a Intervention XX% operationally Peripheral XX% excellent QX versus also operationally XX% versus full sales and and 'XX. organically XX% and organically

being both used devices, Our innovation portfolio with [indiscernible] our growth more still metal our was half This ongoing led by with the in to than QX [indiscernible] performance importance remains clinical procedures commitment the and evidence. underpenetrated of the underscoring market of drug-eluting [indiscernible].

venous, our technology. vein [indiscernible] Varithena, led varicose In by market-leading QX

patients. embolism and real-world by set in for PE, data fourth pulmonary [indiscernible] therapies was largest Additionally, supported evaluating real quarter, near real-time advanced growth the

with Our low performed therapies. portfolio digits fourth [ XXXX, and in individual cancer ] oncology well and strength across in extremely robust of franchise growing our quarter embolization technologies double

continue to common liver trial, and We TheraSphere of ROMAN and the combination in with our enrollment which [ the expand ] will of treat type clinical in immunotherapy, are the pleased access efficacy to cancer. to use have look evidence safety HCC, most commenced primary

operational DCB coronary clinical globally. franchise providing full XXXX. sales imaging expect full patient growth for On and and very regions [ coronary Cardiology driven for restenosis the sales indicator performance the the versus continues its -- and fourth strong first ] our therapy Within the instant AGENT full be the with year full first need. balloon for our growing and year tremendous Balloon the fourth franchise and of U.S. Cardiology of the a quarter XX% a in Interventional year unmet Drug-Coated delivered tremendous and and solution this half quarter quarter Japan, approval grew XXXX. organic well U.S. in we the quarter in for in and therapies Cardiology, will for AGENT international the by physicians year, year. was -- in drug-eluting both AGENT now XX% perform basis, delivered to

the in our in treated valves and with technology globally. full ACURATE have fourth by structural digits XX,XXX both year heart a to Our date grew and basis, we led NeoX double ACURATE of patients than quarter now franchise Europe, more performance on

ahead, anticipate As we approval XXXX. in we ACURATE in of Prime Europe look

analysis anticipate reviewing we regulatory IDE the However, a VacarPrime planned RCT longer U.S. of of full the patients for X-year in determine to interim now data in from [ of XXXX. the after no our wait U.S. ACURATE we Therefore, strategy. approval ] data, the X,XXX the cohort will

the arm continued in cohort. to the continuing in the enrollment we FDA, with suspending while study durability enroll randomized extended Additionally, single alignment are access in

full expect We following the review. data to information the XXXX have second half in of more

of WATCHMAN full have we the markets, expect with finished launch breadth now 'XX and a sales technology. and into XX% WATCHMAN growth organically Pro, globally FLX the grew the sales record WATCHMAN XX% over year of full in fourth treated on which basis. portfolio with first initial quarter. to patients was major utilization QX and the XX% in we the versus quarter U.S. strong QX move by supported of XXX,XXX launch

We breadth ] LAA of trial, continue our clinical to expand in supporting post-market studying our underrepresented which and are the technology this pleased HEAL and cohort, WATCHMAN patient enrollment with is Pro added within populations. the [ pace including newly evidence FLX of

later We trial year, with simplified SIMPLIFY also drug regimen. forward look FLX a Pro WATCHMAN will to post-implant initiating which study monotherapy trial our this

fourth and both in portfolio high-voltage X% CRM, full On Cardiac digits, mid-single our franchise basis, business grew on ongoing single growth Diagnostics high-voltage grew full by our digits full on outpacing a our core and and digits. market differentiated X% in voltage In driven low 'XX. and performance shock versus our driven business was and Rhythm sales low year portfolio double organically basis quarter grew basis, versus grew investments year a options. innovation. 'XX Management year polarity grew XXXX by QX organically broad a

performance ahead, expect be look in CM market with in the growth core we our As to line 'XX. we

solutions grew Sales both XX% organically win fourth POLARx and porfolio. the XX% Electrophysiology. versus our our versus quarter access operationally grew driven [ ongoing to grew and basis organically and operationally quarter full organically 'XX. 'XX XX%, Turning fourth with ] launch by XX% sales and year U.S.

with the are FARAPULSE fourth organically, to quarter this have for with the and FARAPULSE, supply, immediately. console that Our the U.S. thrilled news growth FDA over XX,XXX to technology accelerated international growing FARAPULSE now enter globally morning market EP improved the treated patients And fueled by we approval date. in XX% we received we

to last in year, invest to indications our the antiarrhythmic efficacy continue We AVANT evaluate study compared a the system Late FARAPULSE to in new evidence safety of access support initiated therapy. and to the to [indiscernible] first-line technology. and treatment clinical [indiscernible] AF drug we for as GUARD

rate at presented safety [indiscernible] [indiscernible] for the permanent X%. of was real-world of of of or stenosis, more which and reports in profile with and or more esophageal Japan, with likely event and bring major platform phrenic in AHA Additionally, [indiscernible] real-world to in China the treated than vein injury technology to FARAPULSE than half less no an innovative of the a data FARAPULSE XX,XXX overall We're expect this Japan reinforced markets patients excited pulmonary approval MANIFEST-XXK the year. this nerve second --

that's I'm adjusted reminder, proud closing, over very our accomplish excited of remain a double-digit year resulting culture adjusted our focused basis expanding of motivated XXXX. to what differentiated the We're growth an drive are able In goals. we talent in XX% margin team, improvement achieve about of by and the in including of EPS our and X% on sales XX% goals X-year full 'XX, EPS XX%. global to and average organic sales in conversion and year the free as plan of our are cash while to adjusted to flow performance growth operating sustaining XXX XX% growth approximately period points, and long-range ahead Those

I'll that, pass financials. Dan the to more to provide of all over on details With it

Mike. Thanks,

quarter fourth from tailwind consolidated line represents of billion our $X.XXX exchange, XX.X% point versus foreign with growth revenue in XX XXXX a XXXX includes and Fourth reported expectations. basis quarter

organic foreign Excluding XX%. X% in in growth, contributed growth operational this from the range and basis closed XX Sales our of quarter. from exceeding $XX acquisitions tailwind was guidance million XX.X% to points XX.X% divestitures resulting exchange, revenue revenue

earnings XXXX our performance. sales to XX% our XXXX, primarily QX of high $X.XX grew per share end guidance $X.XX by range exceeding versus of adjusted of $X.XX the driven strong

represents our full line again, foreign versus point For XX.X% from an the billion year revenue and reported XXXX with XXXX growth includes XX exchange, consolidated year $XX.XXX revenue headwind of expectations. basis in

XX.X% year for basis exceeding from growth, range points this foreign the of growth our guidance exchange, headwind and $XXX organic XX.X%. from was resulting million acquisitions Excluding operational Sales closed revenue in XX contributed divestitures XX%. approximately revenue

expectations headwind gross XXXX basis adjusted XXXX, margin versus inclusive margin of year our Full representing from fourth XX.X% high foreign in XX XXXX, XX% of quarter exceeding grew share versus full year adjusted in $X.XX basis a XX.X%, of per guidance Adjusted $X.XX. resulting earnings to $X.XX our year line improvement point with point full and XXX gross of for exchange. was the a XXXX range the of end

full our be new we expect will as FX launches margin our quarter adjusted adjusted a XX of mix a anticipate margin a result, and Fourth or adjusted XXXX headwinds full margin versus year basis gross XXXX, from resulting investment with offsetting the from rate. slightly our points was In benefit XXXX in operating our incremental XX.X% and manufacturing year capacity XXXX. in improving operating at XXXX below full year we XX.X%,

the basis support XX to to expand XX points XXXX critical key to adjusted points with flexibility goal to long-range XXX expect plan over of basis another for XXXX launches. progress We investments operating years X by balancing towards our in XXXX margin

basis, a reported of operating operating was GAAP a in XX.X%. margin full margin fourth quarter year resulting On XX.X%, the

tax $XX interest discrete our the expenses from below in [ including basis, other expense of million, quarter of and compensation year expectations. full fourth interest was an line, ] stock the in resulting and rate Still items favorable year line fourth XXXX, and million, with adjusted benefit adjusted XX% the XX.X% tax the for adjusted On quarter accounting. our and $XXX full totaled other

for again, tax the for with Our fourth expectations. rate was year, and the in XX.X% XX.X% operational quarter line full

the was capital $XXX $XXX billion average X.XXX and million, diluted shares Free QX with operating from weighted Fully flow XXXX. net at activities, full shares of quarter million cash for ended $XXX year for million billion less shares X.XXX outstanding in expenditures.

$X.X items, flow special expectations. $XXX cash year both was line Excluding billion, was flow adjusted XXXX Full free $X.X was and free million. cash billion cash adjusted flow in with

billion, $XXX other $X acquisitions, in For restructuring, approximately litigation payments special XXXX, cash to to we million includes of related free excess be flow full items. expect year expected of and which

was gross XX, debt and of As we on million $XXX leverage hand XXXX, of our X.Xx. December cash had

the close. which to and to Axonics determined expect through on be or will the We fund time prior a of hand debt, of new mix cash at acquisition

Our offset from strategic priority by M&A capital annual repurchases grants. employee top allocation remains share followed to tuck-in stock dilution

December $XXX a Our of as funds. the through legal reserve is million versus qualified already $XXX decrease of was settlement XX, million $XX of million prior this quarter reserve funded our

the year guidance through and Now quarter XXXX. the for full I'll walk first

XXXX XXXX excluding year XX rates, full growth based basis year revenue current foreign operational exchange, we of be contribution a be year to XXXX. XXX acquisitions, of XXXX, point X% X.X% versus full closed in to expect approximate on to a XX%, X% to range in revenue X.X% excluding We headwind to a organic an XXXX growth basis full X% be from reported expect from expect range growth to versus revenue point we

XXXX revenue X.X% XXX range operational XXXX to organic first from point in growth headwind based to excluding XX.X%, We first in X% a expect exchange expect growth be first growth we be quarter revenue current to point a of of range an first rates, be approximate versus XXXX, basis quarter XXXX. to closed excluding XXX acquisitions, quarter X.X% QX to to quarter expect on versus X% from foreign reported basis we a contribution XXXX X.X%

We approximately be below-the-line full $XXX year expect XXXX our million. adjusted to expenses

an of a enacted of XXXX including guidance forecast approximately full Under and XX%. X current operational under and legislation, tax Pillar OECD rate adjusted XX% approximately year rate issued laws rules, we tax

proposed operational we tax of basis the XXX monitor passed drafted to globally, to R&D would XXXX. to in law U.S. our The expect repeal rate including points currently to legislation capitalization. continue approximately tailwind law tax a partially We as currently be were

to share hedging adjusted range X% be $X.XX approximate an including exchange to representing a rates which headwind will current to $X.XX year. in XXXX, expect $X.XX earnings We through recognized foreign ratably XX% existing per at growth be of full versus contracts, and year from the

first earnings per expect to quarter adjusted $X.XX. of a be to range We share $X.XX in

highlights and information, and guidance. Investor website check results our QX financial details QX Relations operational which more XXXX on XXXX please year full For more for and outlines

In XX%. look to our of XX our of of EPS revenue executing XXXX operating organic and performance X% XX to growth, growth forward XXXX proud points basis expansion to X% adjusted closing, and to X% guidance very I'm adjusted of margin on

Before I Lauren moving of key wanted strategy the the potential them a of Q&A, to A turn quick part provide it talent a I back update. over set to broad to our throughout for give individuals high is company experiences.

for As part Urology our role of to business business. many Lauren spent effective Axonics previously importantly, become our this, leadership key Global financial Tengler will playing business the the for making of uniquely X, a integration qualified unit March Controller global the this her business, years Urology opportunity. the providing Lauren and within in

Monson team. contributions transition, her [indiscernible] Lauren's our Following our investment join [ for I and know in to ], will the in Officer, Investor John Chief Lauren role. the John and Relations leadership the rest thanking move Accounting and community the to of currently me leading will function, welcoming

With that, the moderate Lauren, will who it to back I'll turn Q&A.

up minutes Thanks ahead. for please go Drew, for let open let's much, as In question. Drew, or as order many Dan. next to please possible, yourself questions the to us take so so. to X XX questions it

Robbie The JPMorgan. question Marcus from with comes Instructions] [Operator first

biggest into X And the congratulations, quarter. this formularies? a to FARAPULSE think the And over of XXXX approval included take phasing see drivers the year? hospitals WATCHMAN ask to today. in will approved on about how product in year? long to good what's Congrats on and to Wanted Lauren, FARAPULSE. it on on and for got guidance get Wanted really How promotion.

fourth WATCHMAN, but very had in little XXXX? second growth should on potential then for quarter, look WATCHMAN thinking growth plus And -- good still a slowed about a be the XX% in How and bit. it quarter we

on the larger growth an clinical year, terrific product comments. excellent larger us. likely for FLX go for for XX% script It's share quarter full as with you in on to and Rob, throughout you Thanks, touch platform. in cut and to in exceed WATCHMAN WATCHMAN start the for for the It gets Sure. back a be had know, the while, U.S. with year. continue total know, we because I work. first percent the of a Pro, investments more can the XX% rolling [indiscernible] we the out WATCHMAN. But and mix We'll of the if as as XX% making the those just U.S. quarter, And we're I'll our that interested.

is So that, to which you continue a platform. see differentiated

the that sheet in we're the well. clinical is likely market FLX doing the So Pro WATCHMAN and XXXX durable to as and be work in

significantly gain clinical and We continue widen aim we to share, opportunity through market the this to expect to trial.

ahead So WATCHMAN. full steam with

of career, for we the that. expect PFA day and we this Boston FARAPULSE, hospitals, first quarter approval On contract exciting and expect, in lot as in a We out experience impact did rolling FARAPULSE that the goes seen platform contracting and the on work today really with Scientific more you to but based we exciting. maybe FARAPULSE. somewhat significant most year our the we've enthusiasm have much capital it had I've on the anticipate doing platform results for and have my in approval And globally with Europe approved getting receive was with we as be in on the a getting that might as first quarter to and to

that European Our we've success enjoyed.

Our team is trained.

We have team. installation

it. We continue to in invest

EP So excited market aiming about with PFA what think disrupt the we're premier to really the is we platform.

Wuensch Citi. question comes from next with The Joanne

half 'XX, yet, on think I be? you of of what outline suspect you a opportunities those there don't and sort this it the looking quite Japan could But may approval if you're questions call. in I want to and of leave for lot will second China be FARAPULSE

some such the a And highlight of POLAR profile cardiology sort quick higher give companies AGENT? and then of can you on as just

Yes.

of countries, in in with we the me significant Japan, help can are POLARx we and a scale, we've EP under lot Ken So, markets largest China. in, represent XX market. those In the But obviously, opportunities our the particularly compete out. currently call in that Japan it, last, months momentum built China over They're and launch.

think that Japan, know, grew, I our in XX% So over business. EP I don't

And Japan the more for of the second in of will with next half leg stool the commercial us. Japan capabilities have approval FARAPULSE Japan growth so we year this really eventual the team in a scaled and in in be

a So lot confidence more in bigger. may there, of China market bit in a underscaled that We're even China. be

investments So we'll lot of be making a there.

We brand-new EP about leader. in in China. China. the the have a clinical June We're It's of second investments, under commercial our year so Chang, approval around business investments excited to we'll be have additional making hope in half and

will So in drivers those be in for nice significant more growth XXXX. us 'XX

to And comment you do more Ken, AGENT, FARAPULSE? on a bit want

pandemic. FARAPULSE, on realize, comment I to it exciting in I terms of right? a day. is I mean, AFib global hate but it and love Japan the is a is we pandemic, use think China, questions Joanne, about to specifically word to very got I'd Again, disease.

second Japan and approval to that half. in we I that, us the both anticipated in think, got think as the as of already the strength Now have pleased I approval -- the commercial And that clinical us about strength has said, Europe date. times, said patients as experience clinical really, trial with, we led treated to we're that greater from the update data, look right, Mike to that FDA to those of China. XX,XXX than really Again, the and having the data rapid our well we it's approvals that led in and

are much think get important terms access very patient technology. and much I going until currently to to see we're important are large that markets they populations don't ablation we out of in expect material both but too to into large that XXXX, really of and underserved really So and

The comes from Fargo. next question with Wells Biegelsen Larry

here U.S. a about can FARAPULSE, upon manufacturing finish on capacity FARAPULSE On in launch? of Congrats catheter you strong and for console approval talk the and the the the

business this in reason year, you the And 'XX. growth grew lower expectations 'XX? would XX% be for why Any QX in EP

the comments the the NeoX, Europe something Prime, please in around what to ACURATE U.S.? sizes with have you of larger is other your it the And to for like NeoX and are ask sounds I clarify which size, happened implications

team FARAPULSE. with global what Larry. to while Thanks, eventually months and chain Europe the the past a and tremendous XX to supply they've Starting FARAPULSE this for we they've launch supply as acquired group done the a just Really highlighted. building expand of and recently the U.S. done we the ago in Asia, in proud over that very but capabilities

We are now improved numerous catheter Europe in our -- fourth supply. We ready significantly the catheter console we're in go. centers and and quarter to opened

we, don't launch, the Europe approvals or we've issue anticipate to support being in continue locations. to an to So the point, manufacture this facilitate made at supply and U.S. to and given capabilities investments that multiple

launch supply work in team, to great and So by the ready we're chain the this U.S.

NeoX Prime the in we in Europe. we NeoX, continue continue have XXXX. well the than faster what On ACURATE XX,XXX we I And think earnings number are Europe. in Europe to market ACURATE as track points, to for overall grow Implanting, do called very I mentioned the with in script, in maybe and X is on just is

forward So to that move planned. continues as

-- Neo ACURATE until the for likely will not to receiving full of we in to readout based ACURATE script, interim the of follow-up forward. the our the With will the for be we XXXX full that, as X,XXX patients. we analysis, and And wait now need in a result XXXX, of as the study of end mentioned I for to IDE determine trial, on X-year near we respect path approval don't wait the

Kumar from Evercore with comes question ISI. next The Vijay

really through little what are back half X% coming looks launch. it FARAPULSE, be guidance just a have from strong should to fiscal on you to year. Congrats Can we one BBP Maybe X% that ahead. pricing It's us like the X%, perhaps assuming that bit assumptions aware the FARAPULSE that here, [indiscernible] prior a on changed? And Dan, impact walk guide just the in Is Any finish right of? X%? perhaps Dan. for for or ] [ you in 'XX? assumed a

Sure.

change no same assumptions been, So there. the the [ ] VBP as are really they've always

GUARD, QX. launch saw in issued press FARAPULSE timing moved release up you AVANT the of As when expected the December to on we we

we've terms X% QX revenue the X% and year quarter and first been of full that the So anticipating in FARAPULSE. growth to launch X% QX to of a approval for X% contemplated

that there's QX, comes more QX contribution QX. but Mike some As to probably in said, of contribution in

X% -- overall has to contemplated guide. X% So the the in has that

pricing. then And

were what to in would be I say on is the and goal we flat is So XXXX. in XXXX flat pricing again basically

versus impact goal XXXX likely would So in XXXX. no be the

here? impact Sorry, on days Dan. days, Any

of all the the year. the full a the a noise all X% X% contemplated world in to It's No, around days, days and there's year. guidance, through for -- lot lot obviously, the in of all

The comes from Antalffy with next question UBS. Danielle

follow-up a NeoX, I ACURATE if Just could. on Mike, question

did appreciate So the provide. that comments you

Just giving curious, I long-term your read sticking for XXXX. right that here sales happens what strong guidance timing NeoX I is to regardless the pretty of growth here obviously, with mean, guidance ACURATE you that there, and mean provide? you're you're

Okay. We'll.

in. way work I'll my

while. go Once Excited in come for in for Urology. move out. We're Lauren excited a to to Lauren John and to to

Yes.

change over the you as committed we to where question, Investor in answer provided at your grew we are that no 'XX we to XX% and to organic X% XX%. pleased with 'XX to the 'XX CAGR the performance, Day, fully absolutely know, outlook So that growth period

goals. financial absolutely those change to So no

size the continues ACURATE Europe. that's to physicians, European well by every used It's and we're excited in larger there. product do many about approved a getting day

] accurate we over for in approval that disappointed the XXXX. Goldline are We [ didn't get

So end there we year need data followed this wait at until for XXXX, read full take up and in and out sets of likely to from terms we'll are Investor financial Day. the it a we into the for we're launch to really this in that But at year this change end point, absolutely we year gave launch. U.S. and disappointed next of no the very the not guidance to but that going of our

Okay. Great. welcome, And also John.

Sorry, leave mean you I did out. to

The with Bank of next question from America. comes Travis Steed

could we the separate? pretty to Maybe TAVR was? have you at us for the the I'm does confident whole now like one what to X-month a more data U.S. curious need TAVR. saw the you Could at a the X just launch? put that on Was follow-up that data, at TAVR interim risk? think line launch if Or wait this look, for remind year, look U.S. are X-year you what look you still a interim in you

hear to you able Are okay? us

can I you and hear loud Yes, clear.

you and ICT you Sathananthan Officer, Dr. Heart, comment bit. X Medical Structural for Chief a know, ] maybe our [ Great. could as is

about Yes, the the I'll comment take just data.

clinical So essentially, the is trial decision an made full was It study as note the just with X-year active to is we await planned the analysis, the a in what data. still part happened clinical that ACURATE that interim of follow-up. active important IDE study to

result, a related cannot disclose trial the as so any at this data And time. to we

said, Mike study as readout full of a a second expect, will We following in the data review. half XXXX

with TD question from The Cowen. Josh next Jennings comes

year. market on, expansion cardiac in driving any ablation think a incredible growth fourth of delivered promise strong of percent I businesses seeing as this international the going competitors cardiac the electrophysiology your What's almost ablation for there market? in Boston market. international to end mean quarter, growth going Or I the PFA on XX-plus for about Congratulations international their wanted internationally is really ask year. in some are it's this well. market strong XX% early? of but pricing dynamics the we I growth,

there and I some United you driving get PFA that your Just to market wanted have in expansion, details detailed launches translate could the Investor Day? in States think whether which to guys

to you Dr. a at want it? shot take Stein, do

Josh. And Mike. Yes, thanks,

how the Again, earlier, the -- safety as scale, I reflects, just right, parse instance, And XX still experience in contributed at realization physician growth StablePoint from of for increasing age but it you of And X/X or efficacy ablation on adults in things a getting the is really the cardiology here. I can global you incredibly drugs referring of is think as see for fibrillation begin over think, arrhythmia. know, community I couple really for is each. worldwide. It's we effective think I much it's more of technologies. the think again, will in underpenetrated of about -- like that community, us market. effective. relative the I right, much a a But fact, an I all I AFib POLARx know don't and the it factors don't atrial is pandemic it's said literally that incredibly incredibly common U.S., that is just I with out

of a the ablation. effective. data it already FARAPULSE, is And promise right? then also FARAPULSE layer it's It clearly with as top least and that thermal takes And procedure much And the you effective, at efficient on that's is safer. than more

And to underpenetrated into centers scale get this population. start and so better, And this docs out that to enables medical right? much

accelerated of short And a begin answer, population underpenetrated it's with. that, long-winded a on both the to you So maybe answer the is, have impact dramatically FARAPULSE. of top then but

question Newitter The with Richard from Securities. Truist comes next

your And At expectation other franchise is in curious, the curious done -- kind finish a question what I'm to level U.S.? that commentary the really share time, indeterminate you next are on for on Day, talked Congrats guess trying just of I'm out TAVR. and to going year. you've relatively gate. your something market approaching the back the change of view of does there a quickly could disrupt an of capabilities. XX% steps outlook U.S. bit. the to My focus you Does the I anything that of I'm in market a is confidence your Analyst have just which strong just to I just the the with then with for the had with that U.S. TAVR? in disruption over first in the follow-up. what change markets

Yes.

a than to in done XX,XXX don't clarifying the continued valves to set few Europe, points. an Just have row. basis. physicians Again, and grow use know, in faster we that it a market and there routinely we XX where, for, everyday I quarters Continue on

the progress, getting I excited is So in size and the large we make time nice believe XXXX about we're valve Europe. approved period.

In the state market for would quoted U.S., share a honestly, I -- we've in TAVR U.S. the goal of we all, never first that

what based models results that confident sure or we as driver to on ACURATE was have But set meaningful at been Day. if not seen a XX%, be in So the in ability never the your we've our Investor I'm you we in put not. U.S. that stated growth in Europe, we've always

of disappointed we script, going need having FDA to talked take full that follow-up wait we'll launched and from year just we then data X-year the the to this result year-end and data data, with full out the as based in it that as submitting we on and for by the read we mentioned, and about the there. we're are now and X,XXX XXXX, this, working patients highlighted that that As on not in Janar a have the

So the -- we is trial as Janar still said, active.

do expect XX%. we X-year to we're over period, coming So our not XX% news to off any X% growth this the alter of organic

still We group. fourth continue faster for all we're continue to of EPS quarter. grow be than lot of readout will data on most and than that driver committed a we're targets. depends to peer And but to financial those drop big ACURATE our And growth peers it that us, a our faster very hopeful in

for your months? in the on I'm XX Axonics guys Okay. tuck-ins as of obviously, first bit just have kind think of be think this next capital about year. XXXX, on a aggressive as you opportunistic early congrats digestion opportunistic and she deploying been You we in little of aggressive kind of remains, do a the Relievant of kind should And but will just curious over then on goes, you've steady been recently past? in period you how priority just and or we and mentioned, as active how maybe more and M&A,

take can one. I Sure. that

as did, pleased that. most we recent mentioned, the you super with So deal Axonics,

close it's Axonics think as back, into a to Scientific. and Boston It's that excited the really tuck-in I family. -- types with, -- of welcome is deals, team look BSE think super we I well we're and you classic for these the one do have that

remarkably As #X of consistent said, capital been allocation M&A long still we'll over priority be for is period continue a and Tuck-in to us, we've the time. I active.

over delevering active we take In is event on -- need how terms our are relative today this the bit near We'll additional over period of a to be major not major a the over debt back and do. of little a This to very a period reasonable time. medium leverage then that a right time to goals. is we where of to like of term, event

for to active I'd tuck-in continue space 'XX beyond. M&A the So look and in to us in be

Okay. Again, an on XQ. congrats outstanding

question comes Stanley. with next Morgan from The Wood Patrick

and [ pushing where really with I Management, sizable distribution I'm there, Axonics, the like of that's thinking you if drive How some primarily whole across, ability slightly I I just at OAB the Congrats, right. the free distribution I'm just numbers, to having correct But the the played previously push but stick curious, if a feel faster you me correct Sandy in in had has about like adoption up faster network through I'm that are thinking very Street guessing that that's ] to acquired asset? commonalization closed how growth least end with yet. to wrong, Urology network? and kind assumption appreciate Lauren. are Boston I'd really in about but me, once with of and numbers you've Axonics Stone guess, of areas. but bunch it hasn't different a

since We taking platform years and Axonics done this The we this what of yet. haven't for in ago job closed hope speak team team Sure. starting growth an The hasn't significant amazing it closed Well, at can't year. has to a strong company yet. it market. first half with at much is Axonics them, share too double-digit the

awareness. their a marketing As that possess just commercial they areas, the that excellence remarkable technology [indiscernible] they done gained and expanding direct-to-patient have, where core few a market also data to The they the one leverage and in share. gain the job that of through -- clinical

and the this So days. is significant of awareness opportunity still a early this patient treatment is global

the CAGR And market the why we reason the so they opportunity. one on see have, global acquired that the long-term technology the that's and company based was momentum we

today for the select nearly would to That's bring something given here future this all in we market is outside the as make The to us markets have. more it sense to U.S. that U.S. the data we'll evaluate

As within our through of you commercial channel significant business units Urology. we all mentioned, a have our different business in Urology

We don't area. us. adjacency for any fit. competitive product have in is is an ideal an So this this It

So aim terrific date. to has will level, Urology to that done nice the we us compete to take force a to team Axonics customers. is competently next a job that adjacency more it's allow but with But

verify, And for one we more do just have time to question?

Yes. please. One last question

question Research. with That Michael will from Wolfe Polark come

heard we all year-on-year gross Dan, margin be in the know, price Middle in maybe script world down as East the I 'XX a is question. flaring. calmer on seems to cost. for The to guide. ask But slightly flat I'll the

in any for And so curious, you like? look two, in of are if real have And the that does seeing cushion so, in kind you impact And field? one, any built from what I'm time, those push cost events?

answer Yes, a give bit short and the you longer answer. little I can

that is we've contemplated all one short the So that.

to Our to relative team is super close supply global everything our network. chain

guidance gave And minimal. so and in we -- today they're is have and giving that that, on there that us everything the what know contemplates the what that we guidance impact which the we

Overall, gross little longer bit on answer. margin, a

expansion we at true. which recently, all contribute we probably in right, expected those have prove that's track to to know, that's 'XX, you be last points that goals we as basis challenge areas the drive out in 'XX, where time would that's pretty will below. a most pretty are Day came be much it XX as to of P&L. at to our a But slightly said to either managing then the okay. And record over we the going look at There If said you right lines of The September, P&L thing XX.X%. we as in Investor solid many be other of year. And margin

one kind And other of to But of kind elements as I'd tailwind, X relative out enter will materials last little factors of contracts that's right? up or play and below X it's already reminder, a the that bit -- things. year. put many general again, inflation. headwinds And probably that of a will 'XX we tailwinds into are the in slightly for macro at inflation a have that we year. for improving last 'XX, So for XX.X% to So is and us at and point

inflation, I'd and 'XX more want to not So benefit. there, in but only there's side margin we also in see But don't gross even full benefit the total. like 'XX, macro from that for of to believe

our And then mix.

then of the to Investor over get have, line probably well. good that Gross XX% So that's the won't get investments focused to 'XX as there. to headwind And are said margin X long-term we to FARAPULSE great today, foreign used maniacally growth, doorstep getting the then and company 'XX. approval headwind back in continue we're of many and and side, the make that thing committed But get we that's margin of kind launches [indiscernible] because we've XXX on but our in also puts 'XX. XX% as the of problem kind a growing on XXXX XXXX. X% had when then goal of we Day, in at mix overall And 'XX a we're to our that sight manufacturing need And sales X% are a for operating and exchange other to right bills I 'XX in it of was I the points of in exciting the to support in year pay last to we XXXX, lot years. north Recall, be certainly will for a basis this in absolutely to year. and 'XX in us but XX% think as

get your follow-ups, if appreciate to don't We today. any Relations to question the have interest in you hesitate or us to joining please Boston If unable your for team. to reach we out Scientific. Investor were Thanks

Drew pertinent all details for will of disconnect, give the replay. you Before you

note, in hour until recording X, using either XXX a by XXXX Eastern or XXX will Please XXXX available XXX XXXX dialing XX:XX replay XXX Time. be code X at you. X XXXX, February X p.m. XXX Thank

presentation. today's concluded. you The now Thank conference has for attending

may now You disconnect.